Class 2 Device Recall PadPro MiniInfant Multifunction Electrodes 2602 Series

• Date Initiated by Firm: February 23, 2018
• Create Date: March 24, 2018
• Recall Status: Terminated on September 17, 2020
• Recall Number: Z-1175-2018
• Recall Event ID: 79337
• 510(K)Number: K002280
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H; ; Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
• Code Information: Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501.
• Recalling Firm/ Manufacturer: ConMed Corporation; 525 French Rd; Utica NY 13502-5945
• For Additional Information Contact: Field Action Support Team; 315-797-8375
• Manufacturer Reason for Recall: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
• FDA Determined Cause: Process design
• Action: The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below: 1. Email to: padpro2602@conmed.com 2. Fax to: Field Action Support Team at 315-624-3225. 3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.
• Quantity in Commerce: 18,720 units in total
• Distribution: Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = MEDICAL DEVICES, INC.